PURE EP™ System

NASDAQ: BSGM

BioSig Technologies, Inc. (NASDAQ: BSGM) is a medical technology company developing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals within the rapidly growing $4.6 billion electrophysiology (EP) marketplace. Led by a proven management team, world-class Board of

Directors and Scientific Advisory Board, Los Angeles-based BioSig is preparing to commercialize its PURE EP™ System. PURE EP™ is a signal acquisition and processing system designed to assist electrophysiologists in making clinical decisions in real-time to help identify areas of tissue that create a heart rhythm disturbance (arrhythmia). PURE EP™ is designed to support catheter ablation cases, working in parallel with existing recording and mapping systems. BioSig's goal is to improve the standards of care in electrophysiology and increase the number of patients who can have their condition successfully treated during the first procedure.

Key Growth Drivers

  1. Advanced Technology - The non-invasivePURE EP System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The system is indicated for use under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. The PURE EP System aims to minimize noise and artifacts, and acquire high-fidelity cardiac signals. Improving cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving accuracy and efficiency of the EP studies and ablation procedures. The PURE EP™ System received FDA 510(k) clearance in August
    2018.
  2. Market Opportunity - Market Research Engine states the global electrophysiology (EP) device market is expected to exceed more than US $8.5 billion by 2024 and is growing at a compound annual growth rate (CAGR) of 10.6%. The Company also operates within the rapidly emerging field of bioelectronic medicine, estimated at $3.75 billion in 2017 with projected annual growth of 14.2%.
  3. KOL Support - First successful clinical use of PURE EP™ System was led by two globally recognized leaders: Dr. Andrea Natale of Texas Cardiac Arrhythmia Institute and Prof. John M. Miller of Indiana University. The Company achieved proof of concept validation through UCLA, and performed eighteen pre-clinicalstudies at Mayo Clinic, MN under the leadership of Samuel J. Asirvatham, M.D., Mayo Clinic's Vice-Chairof Innovation and Medical Director, Electrophysiology Laboratory.

Market Snapshot

NASDAQ: BSGM

Price (1/03/20)

$6.14

Average

75,681

Volume (50 day)

52-Wk. Range

$4.06 -

$9.97

Float

16.24M

Shares

22.17M

Outstanding

Market Cap

$136.13M

Recent Highlights

  • Announced partnership with Reified on development of artificial intelligence (AI) solutions in healthcare
  • Commenced its first clinical trial for its PURE EP™ System
  • Opened a technology development office in Rochester, Minnesota
  • Signed a new licensing agreement with Mayo Clinic in Sept. '19 - 3 new agreements signed in Nov '19
  • BioSig's subsidiary NeuroClear Technologies, Inc. raised $3.7 million in an initial seed round
  • Allowed additional foundational US Patent for its PURE EP™ System
  • Appointed five new senior industry hires: Andrew Ballou - Vice President of Investor Relations; Julie Stephenson, BSN, MBA - Senior Director of Clinical Affairs; Olivier Chaudoir - Director of Marketing; Manasi Patwardhan - Director of Strategic Planning; Sasha Gentling, CFA - Director of Business Development and Investments
  • Added as a member of the Russell 3000® Index
  • Appointed Jerome Zeldis, M.D., Ph.D,, Samuel E. Navarro, and Martha Pease to Board of Directors
  • Received $4.6 million in cash warrant and option exercises
  • Announced that the US Patent & Trademark Office allowed 33 patent claims covering its PURE EP™ System
  • Successfully conducted patient cases using PURE EP™ System at Indiana University School of Medicine, Texas Cardiac Arrhythmia Institute and Greenville Memorial Hospital

BioSig Technologies, Inc.

Contact:

Kenneth L. Londoner

Phone: +1 (203) 409-5444, x119 klondoner@biosigtech.com

Investor Relations

Phone: +1-310-620-9320 ir@biosigtech.com

Investment Catalysts

PURE EP System

Proven Team

Investment Highlights

Proprietary Hardware and Software with

BioSig is comprised of a stellar cast of a

Member of the Russell 3000® Index

Advanced Signal Processing Capabilities:

proven

management

team

and

a

premier

Successfully Conducted First Patient Cases with

To Improve Signal Clarity Through Reduction

Board of Directors with high levels of inside

PURE EP™

Management and

Insiders

Own Approx. 68%

of

of 'Noise' and Artifacts

equity ownership.

Shares

To Minimize Need for Repeat Procedures

BioSig

brought

together leading

physicians,

10-year Strategic Collaboration with Mayo Clinic

To Preserve Important Clinical Information

Core competency in Basic Science, Capital Markets

executives

and

engineering

experts from

and Capital Architecture

To Shorten Procedure Times

leading medical centers of excellence,

IP Strategy Led by Sherpa Technology Group and

To

Increase Confidence

in Performing

healthcare programs, Fortune 500 Companies

Sterne Kessler Goldstein & Fox

Complex Ablations

and elite

educational institutions

including

FDA clearance achieved; CE Mark-2020

Proven Management Team and Board of Directors

Mayo

Clinic, Mount

Sinai Medical

Center,

Global and Growing Addressable Market

UCLA,

Johnson

&

Johnson, Nasdaq

and

Operates Within

Rapidly

Emerging Field

of

Prudential Securities.

Bioelectronic Medicine

Kenneth L. Londoner, Chairman & CEO, has a

High-GrowthSector Earns

Innovation Premium,

Aggressive M&A

wealth of knowledge and experience that

Collaborating with Leading EPs from:

spans many decades and includes founding,

Global

EP Market-10.6%

Growth from

running, and serving as Director to a number

of life science companies. Mr. Londoner began

2016-2024 reaching $8.5B by 2024

his career with J. & W. Seligman & Co., Inc., a

Global Ablation: 865,000 patients in 2015 to

leading institutional money management firm

1,350,000 in 2020.

where

he

rose

from research

analyst

to

  • Global Procedure Growth: 8.4% annual rate, managing $3.5 billion in mutual funds,

from 973,220 in 2017 to 1,455 million in

pension funds, and international assets. Steve

2022.

Chaussy, CFO has acted as a consultant for

Current Cardiac Arrhythmia Epidemic (1 in 18 or

The FDA (www.fda.gov) presented at the Heart

small publicly

traded entities

with a special

14.4M Americans)

Rhythm Society 2017

and spoke of the

emphasis towards SEC reporting and

Two of the most prevalent and potentially deadly

compliance; and served as CFO for a large

importance of technological innovation in the

private distribution and wholesaling company,

types of arrhythmias today are Atrial Fibrillation

EP field.

(AF) and Ventricular Tachycardia (VT). Ventricular

where he gained international experience.

arrhythmias account for approximately 450,000

Their many accomplishments

and years of

sudden deaths per year in the United States

alone. Catheter ablation is fast becoming a first

experience of the management team, as well

line therapy, driving demand for improved

as the Board

of Directors

and Scientific

technologies. AF is the most common arrhythmia

Advisory Board, is unmatched and provides

affecting 33.5 million people worldwide, with as

BioSig a clear advantage in the market.

many as 6.1 million people in the U.S. now and

expected 8-12 million by 2050. AF increases the

risk of stroke 4x to 5x and contributes to

~750,000 hospitalizations per year. The direct

Management

Directors

cost of AF is approximately $6B annually; adding

other indirect costs brings AF total cost to $26B.

Kenneth L. Londoner, MBA, Founder, Chairman, Chief

Donald E. Foley, Director - CEO & Chair: Wilmington Trust; Sr VP, Treas & Dir: ITT Corp; Asst

Executive Officer, Director

Treas: International Paper Co.

Endicott Management Partners; J & W Seligman & Co; Director: Alliqua

David Weild IV, MBA, Director - Current Chairman & CEO; Weild & Co.; Vice Chairman:

Steve Chaussy, CPA, Chief Financial Officer

NASDAQ; Head of Corporate Finance & Equity Markets: Prudential Securities

Liberski Inc; Anna & Co; Penske Truck Leasing, Ford, Hogg & Cobbe

Patrick J. Gallagher, MBA, Director - Mg Dir: Laidlaw & Co.; Kinex Pharmaceuticals;

Natasha Drapeau, Executive Vice President

Director: Cingulate Therapeutics, BDR Research Group, GC Capital Partners, Kidder Peabody

Jeffrey F. O'Donnell, Sr., Director - Current CEO, Director: Trice Medical; Current Chair:

IG Group Plc, London, UK; Augeous Consulting, Geneva, Switzerland

SpectraWave; Director: AdvaMed Accel; Founder: Embrella Cardiovascular (sold to Edwards

Barry Keenan, Ph.D, MBA, PMP, VP, Engineering

Lifesciences); CEO: PhotoMedex, Radiance Medical (Cardiovascular Dynamics), Kensey Nash;

Medtronic, Nexeon MedSystems, Alfred Mann Institute for Biomedical

Sales/Mktg Mngt: Boston Scientific, Guidant, J&J; Former Director: Cardiac Science, Endologix

Engineering; Alfred Mann Foundation for Scientific Research

Andrew Filler, Director - Current Partner & General Counsel: Sherpa Technology Group,

John Kowalski, VP, Sales

Nanosys; IP Counsel: Previvo Genetics; Board: Aira Technologies. Former: Caliper Life Sciences

Biosense Webster (Johnson & Johnson)

(sold to Perkin Elmer), Weil, Gotshal & Manges

Jerome Zeldis, M.D., Ph.D, Director - Chief Medical Officer and President of Clinical

Andrew Ballou, VP, Investor Relations

Research, Medical Affairs Drug Safety, Quality, and Regulatory at Sorrento Therapeutics, Inc.

Janney Montgomery Scott LLC., RBC Capital Markets

Samuel E. Navarro, Director - Managing Partner: Gravitas Healthcare, LLC; Former

Julie Stephenson, VP, Clinical Affairs

Managing Director and Global Head of Medical Technology Investment Banking: Cowen &

Medtronic, Boston Scientific, Guidant Corporation

Company

Olivier Chaudoir, Sr. Director of Marketing

Martha Pease, Director - Current Partner and Director at BCG (Boston Consulting Group)

Biosense Webster, DePuy Synthes

Analyst Coverage

ROTH Capital Partners

Laidlaw & Co (UK) Ltd.

Chardan Capital Markets, LLC.

Disclaimer: This Corporate Summary Sheet includes forward-looking statements. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, ability to obtain financing, regulatory approvals, competition and marketplace demand. More information, and BioSig risk factors, are set forth in its filings with the SEC. BioSig assumes no obligation to publicly update or revise its forward-looking statements.

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Biosig Technologies Inc. published this content on 10 January 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 January 2020 23:02:01 UTC